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The human immune system is designed to protect individuals from external sources of infection and internal cell mutation. It works effectively and efficiently until inflammation disturbs its functioning. Once compromised by inflammation, the immune system loses its capacity to recognize antigens and dependably defend the body against disease and illness.
When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body's over immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the body without sufficient strength or time to fight back. When the medical herbs join the body, it can slow down the immune reaction. Medical herbs benefit the physical body; they protect the cells and organism structure and mediate the immune response, allowing the T cells to kill the virus (mutated or not) internally. Such success has been achieved by the All Natural Medicine Clinic during pre-clinical trials.
This clinical study's goal is to demonstrate that the immune system can be rebuilt and retrained, using natural medicine (i.e., medical herbs), to kill the virus without causing the immune storm, and to explore the mechanism by which these medical herbs, which have been used for thousands of years for healing, achieve results.
According to CDC data, as of January 30, 2021, 25,780,144 individuals residing in the United States had been infected by COVID-19 and 435,151 had died as a result of the disease. No drug has yet been identified that explicitly kills the COVID-19 virus. While various vaccines have been developed to prevent infection, the virus continues to mutate, and scientific research remains behind the virus trajectory.
The human immune system, when functioning properly, can prevent the body from succumbing to infections from external sources and from internal cell mutations, including the COVID-19 virus and cancer cells. That is, the defense system comes from nature. This clinical study proves that the immune system can respond to those antigens and kill them if the immune system is given a chance. However, the human immune system can become compromised through inflammation and subsequently unable to successfully prevent infection and cancer.
When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body's over-immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the body without sufficient strength or time to fight back.
Medical herbs can mediate the immunity disorder caused by infections, and mutated cells, including COVID-19 and its mutations. Our pre-clinical study found that the medical herbs inhibit the inflammation expression, reduce the chance of cytokine-storm, prevent deterioration, and reduce the mortality rate. In addition, the T cells can perform their job when the inflammation is under control. The virus and cancer cells belong to antigens that should be killed by natural killer (NK) cells and T cells. This clinical study aims not to provide drugs to kill the antigens, but rather to create the necessary conditions inside the human body to allow the immune system a chance to overcome the antigens. The clinic has used this treatment concept to successfully treat infected patients and cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammation (I) | Active Comparator |
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| Inflammation (II) | Active Comparator | Cough, chest pain |
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| Inflammation (III) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflammation (I) | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| recovering damaged organ | comparing imagen of lungs | 3 weeks |
| inhibiting inflammation | comparing C-reactive protein (CRP) | 3 weeks |
| preventing the antibody depositing on antigen | measuring complement: C3, C4 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| monitoring the antibody level | measuring immunoglobulin M (IgM), immunoglobulin G (IgG) | 6 weeks |
| correcting reversed immunity ratio | measuring cluster of differentiation 4/cluster of differentiation 8 (CD4/CD8) |
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Inclusion Criteria:
A subject will be eligible for inclusion in this study if any of the following criteria apply:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanzhu Hou, CMD, MD(CN) | Contact | 1(301)770-4480 | info@anmedicine.com |
| Name | Affiliation | Role |
|---|---|---|
| Wanzhu Hou, CMD,MD(CN) | All Natural Medicine Clinic, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Natural Medicine Clinic, LLC | Recruiting | Rockville | Maryland | 20852-2235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wannzhu Hou Cellular Structure and its Function is the key for heeling Diseases, Certification and Registration number: TXu 1-938-144 July 30, 2014 | ||
| 24795718 | Background | Rosendahl Huber S, van Beek J, de Jonge J, Luytjes W, van Baarle D. T cell responses to viral infections - opportunities for Peptide vaccination. Front Immunol. 2014 Apr 16;5:171. doi: 10.3389/fimmu.2014.00171. eCollection 2014. | |
| 32802404 |
| Label | URL |
|---|---|
| We widely treat and research infected and non-infected diseases based on recovering the damaged structure and function of cells. | View source |
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When we finish the project of the clinical study, we will share the individual participant's data (IPD) (but is not personal private to share) when the results in the publication
The clinical study may start on February 1, 2021; the ending of the say maybe is December 31, 2022. The IPD sharing will begin after the publication in six months.
Viruses, including COVID-19, are highly likely to mutate. This capacity makes it particularly challenging to kill the virus with drugs. This clinical study designed two groups, both of they used the same drugs, but the treatment group pluses medical herbs, then both groups parallelly receive the treatment, then compare participants symptoms, blood test of immunity, the lungs imagine, and COVID-19 virus index, the difference in both group, analysis the symptoms and the mechanism.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D007249 | Inflammation |
| D013927 | Thrombosis |
| D011024 | Pneumonia, Viral |
| D005334 | Fever |
| D003371 | Cough |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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The participants are randomly divided into two groups: the treatment group and the control group. Both groups receive the same medications, but the treatment group also receives medical herbs to compare both groups' differences on their symptoms and blood data, virus marks.
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The participants will be randomly divided into two groups by computer. The conventional practitioners who prescribe medications for the participants will not know who will go to the treatment group. Participants will know which group they are in.
|
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| Inflammation (II) | Dietary Supplement | Platycodi Radix 2.4g, Peucedani Radix 2.4g, Cynanchi stauntonii Rhizoma 2.4g, Asteris Radix 2.4g, Stemonae Radix 2.4g, Lepidii Descurainiae Semen 2.4g, Plantaginis Semen 2.4g |
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| Inflammation (III) | Dietary Supplement |
Salviae miltiorrhizae Radix 2.4g, Curcumae Radix 2.4g, Paeoniae Radix rubra 2.4g, Persicae Semen 2.4g, Carthami Flos 2.4g |
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| Standard of care | Drug | remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab. |
|
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| 6 weeks |
| tracking the COVID virus marks | SARS-CoV-2 Diagnostic (Molecular or Antigen) Testing | 3 weeks |
| Background |
| Zhou LK, Zhou Z, Jiang XM, Zheng Y, Chen X, Fu Z, Xiao G, Zhang CY, Zhang LK, Yi Y. Absorbed plant MIR2911 in honeysuckle decoction inhibits SARS-CoV-2 replication and accelerates the negative conversion of infected patients. Cell Discov. 2020 Aug 5;6(1):54. doi: 10.1038/s41421-020-00197-3. eCollection 2020. No abstract available. |
| 8666349 | Background | Peters M. Actions of cytokines on the immune response and viral interactions: an overview. Hepatology. 1996 Apr;23(4):909-16. doi: 10.1053/jhep.1996.v23.ajhep0230909. No abstract available. |
| 23263184 | Background | Zhou H, Sun L, Yang XL, Schimmel P. ATP-directed capture of bioactive herbal-based medicine on human tRNA synthetase. Nature. 2013 Feb 7;494(7435):121-4. doi: 10.1038/nature11774. Epub 2012 Dec 23. |
| 29669994 | Background | Dosch M, Gerber J, Jebbawi F, Beldi G. Mechanisms of ATP Release by Inflammatory Cells. Int J Mol Sci. 2018 Apr 18;19(4):1222. doi: 10.3390/ijms19041222. |
| 21293466 | Background | Chen RJ, Jinn TR, Chen YC, Chung TY, Yang WH, Tzen JT. Active ingredients in Chinese medicines promoting blood circulation as Na+/K+ -ATPase inhibitors. Acta Pharmacol Sin. 2011 Feb;32(2):141-51. doi: 10.1038/aps.2010.197. |
| 15630483 | Background | Samuels N. Herbal remedies and anticoagulant therapy. Thromb Haemost. 2005 Jan;93(1):3-7. doi: 10.1160/TH04-05-0285. |
| 30776316 | Background | Soni S, O'Dea KP, Tan YY, Cho K, Abe E, Romano R, Cui J, Ma D, Sarathchandra P, Wilson MR, Takata M. ATP redirects cytokine trafficking and promotes novel membrane TNF signaling via microvesicles. FASEB J. 2019 May;33(5):6442-6455. doi: 10.1096/fj.201802386R. Epub 2019 Feb 18. |
| Result | Wanzhu Hou, et al. Treating Autoimmune disease with Chinses Medicine, Elsevier, 2011 |
| D030341 |
| Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |